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KMID : 1100820140040010015
Laboratory Medicine Online
2014 Volume.4 No. 1 p.15 ~ p.21
Evaluation of the Wisecheck Glucose Monitoring System
Kwon Seon-Hee

Kim Ha-Nui
Ko Sun-Young
Cho Chi-Hyun
Kim Jang-Su
Lim Chae-Seung
Abstract
Background: Glucometers are widely used for self-monitoring and point-of-care testing in diabetes management. We evaluated the performance of the recently developed Wisecheck Glucose Monitoring System (Wisemeditech, Korea) compared to that of 2 other well-known glucometer systems.

Methods: The Wisecheck glucometer was evaluated for precision, linearity, and carryover rate. One-hundred fifty samples samples were tested, and the results obtained from the Wisecheck glucometer, ACCU-CHEK Performa (Roche Diagnostics, Germany) and SD GlucoLink (SD Diagnostics, Korea) were compared to those obtained using the laboratory reference method from the Toshiba 200FR (Toshiba, Japan), according to the Clinical and Laboratory Standards Institute (CLSI) guidelines.

Results: The coefficient of variation (CV) values for within-run imprecision at low, middle, and high levels were 2.06%, 1.02%, and 2.02%, respectively, and the CV values for total-run imprecision at low, middle, and high levels were 2.98%, 2.41%, and 1.88%, respectively. In the linearity test, the coefficient of determination (R2) was 0.9985 in glucose concentration ranging from 48.6 mg/dL to 428 mg/dL (P<0.0001). The results obtained using the Wisecheck glucometer were well correlated with those obtained using the Toshiba 200FR (R2=0.980, P<0.0001). The carryover rate was 0.12%.

Conclusions: The Wisecheck glucometer showed good precision, linearity, and correlation with the reference method. It provided rapid and reliable measurements of blood glucose levels and seemed appropriate for use in diabetes management.
KEYWORD
Glucometer, Blood glucose, Diabetes mellitus
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